MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMBINATION WRENCH 11MM/BLADE SCREW; MISC ORTHO SURGICAL INSTR

Model Number	03.037.031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is jnj employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6), 2021, while the operating room staff was trying to take the instrument apart with the wrench, the wrench broke.The procedure was over when event happened.There was no patient consequence.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity 1) and unknown tfna extraction drive (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1)combination wrench 11mm/blade screw.This report is 1 of 1 (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 03.037.031.Lot: 9412014.Manufacturing site: umkirch.Release to warehouse date: march 26, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the combination wrench 11 mm/blade screw was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the tip was broken.There were scratches on the device but have no impact on the device functionality.No other issues were observes with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Wrench hexagonal 11/blade/screw.Investigation conclusion: the complaint condition was confirmed for the combination wrench 11 mm/blade screw.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMBINATION WRENCH 11MM/BLADE SCREW
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11578622
• Report Number: 2939274-2021-01546
• Device Sequence Number: 19900253
• Product Code: LXH
• UDI-Device Identifier: 10886982070470
• UDI-Public: (01)10886982070470
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.037.031
• Device Catalogue Number: 03.037.031
• Device Lot Number: 9412014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 02/28/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - EXTRACTION INSTRUMENTS: TFNA/PFNA; UNK - SCREWS: TRAUMA